Search results for "Clinical-trial"
showing 10 items of 19 documents
Herpes Simplex I virus impairs regenerative outcomes of periodontal regenerative therapy in intrabony defects: a pilot study.
2011
Aim To evaluate the impact of herpesvirus type-1 and -2 on the clinical outcomes of periodontal regenerative procedures in isolated deep intrabony pockets, in an experimental population with no detectable periodontal pathogens. Materials and Methods Seventeen periodontal intraosseous defects in 17 moderate-to-advanced periodontitis patients were treated with regenerative therapy and amelogenins. Microbiological evaluation was performed at baseline (after the completion of initial therapy) and at 1 year to exclude the presence of periodontal pathogens. Herpesviruses-1 and -2 DNA were quantified in the pocket tissues associated to the intrabony defect using molecular assays. Clinical attachme…
3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-…
2017
Background: \ud Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes.\ud \ud Methods: \ud In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-…
Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers
2011
Abstract Purpose: To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. Experimental Design: The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here…
Pulsed electromagnetic field therapy in the treatment of pain and other symptoms in fibromyalgia : a randomized controlled study
2018
Low-energy pulsed electromagnetic field (PEMF) therapy has been suggested as a promising therapy to increase microcirculation, which is of great concern in patients with fibromyalgia. This study evaluated the effectiveness of PEMF therapy on the treatment of fibromyalgia. A group of 108 women with fibromyalgia were allocated to a 12-week treatment period with an active Bio-Electro-Magnetic-Energy-Regulation (BEMER) device and a similar treatment period with an inactive device. Each patient received active and sham treatments in a random order. Pain and stiffness were assessed on a visual analog scale (VAS, scale 0-100mm), and functional status was assessed by the Fibromyalgia Impact Questio…
Rehabilitation of the severely atrophied dentoalveolar ridge in the aesthetic region with corticocancellous grafts from the iliac crest and dental im…
2016
Background The aim of this study was to assess changes in bone volume after block bone augmentation and placement of dental implants and further evaluate the aesthetic outcome of the treatment. Material and Methods 9 Patients with atrophied anterior maxilla were included in this study. They received total of 21 implants. Dimensions of the alveolar ridge were measured from cone-beam computed tomography x-rays. The bone level at the implant sites was analysed from intraoral x-rays and the aesthetic outcome was assessed from clinical photographs using a pink aesthetic score (PES) scaling. Results The mean gained horizontal bone width at the marginal crest and 5 mm apically was accordingly 2.7m…
The impact of conversion on the risk of major complication following laparoscopic colonic surgery: an international, multicentre prospective audit.
2018
BACKGROUND: Laparoscopy has now been implemented as a standard of care for elective colonic resection around the world. During the adoption period, studies showed that conversion may be detrimental to patients, with poorer outcomes than both laparoscopic completed or planned open surgery. The primary aim of this study was to determine whether laparoscopic conversion was associated with a higher major complication rate than planned open surgery in contemporary, international practice.METHODS: Combined analysis of the European Society of Coloproctology 2017 and 2015 audits. Patients were included if they underwent elective resection of a colonic segment from the caecum to the rectosigmoid jun…
Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised…
2020
BackgroundLow back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise.MethodsIn parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristic…
R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma: results of the FOLL05 trial conducted …
2013
Purpose Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen has yet to be clarified. Patients and Methods We conducted an open-label, multicenter, randomized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide, vincristine, and prednisone (CVP) or six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine and mitoxantrone (FM). The principal end point of the study was time to treatment failure (TTF). Results There were 534 patients…
Liraglutide and cardiovascular outcomes in type 2 diabetes
2016
The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. METHODS In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjus…
An international multicentre prospective audit of elective rectal cancer surgery; operative approach versus outcome, including transanal total mesore…
2018
Introduction: Transanal total mesorectal excision (TaTME) has rapidly emerged as a novel approach for rectal cancer surgery. Safety profiles are still emerging and more comparative data is urgently needed. This study aimed to compare indications and short-term outcomes of TaTME, open, laparoscopic, and robotic TME internationally. Methods: A pre-planned analysis of the European Society of Coloproctology (ESCP) 2017 audit was performed. Patients undergoing elective total mesorectal excision (TME) for malignancy between 1 January 2017 and 15 March 2017 by any operative approach were included. The primary outcome measure was anastomotic leak. Results: Of 2579 included patients, 76.2% (1966/257…